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U.S. Department of Health and Human Services

Class 2 Device Recall Fabius Trio Gas machine

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 Class 2 Recall
Fabius Trio Gas machine
see related information
Date Posted September 23, 2008
Recall Status1 Terminated on March 08, 2010
Recall Number Z-2338-2008
Recall Event ID 48979
Premarket Notification
510(K) Number
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.
Code Information Serial numbers: ARYA-xxxx, ARYB-xxxx, ARYC-xxxx, ARYD-xxxx, ARYE-xxxx, ARYF-xxxx, ARYH-xxxx, ARYJ-xxxx, ARYK-xxxx, ARYL-xxxx, ARYM-xxxx,ARYN-xxxx, ARZA-xxxx ARZB-xxxx (where xxxx represents any 4 digit number)
Recalling Firm/
Draeger Medical, Inc.
3135 Quarry Rd
Telford, Pennsylvania 18969-1042
For Additional Information Contact Drager Service Technical Support
Manufacturer Reason
for Recall
The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.
FDA Determined
Cause 2
Action The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.
Quantity in Commerce 111 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DRAEGER MEDICAL, INC.